Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

This study has been terminated.
(The results were not able to be consistantly reproduced. Thus the trial was terminated)
Sponsor:
Information provided by:
ViOptix Canada
ClinicalTrials.gov Identifier:
NCT00224328
First received: September 13, 2005
Last updated: September 11, 2007
Last verified: September 2007
  Purpose

Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise in numerous indications involving tissue ischemia. In the current study, we propose to examine one hundred patients requiring either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral arterial disease. We intend to challenge patients before and after the intervention, using either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation recovery time in the affected limb is correlated with symptom resolution (i.e. treatment success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter developed by ViOptix, Inc. The proposed study will take approximately one year to complete enrolment, and has a follow-up period of 6 months post-intervention.

Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia.


Condition Intervention Phase
Peripheral Arterial Disease
Device: ODISsey Tissue Oximeter
Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia: A Phase Iia, Non-Randomized Study Using the ODISsey Tissue Oximeter to Evaluate the Correlation Between Tissue Oxygen Saturation and Symptom Resolution in Patients With Chronic Critical Limb Ischemia Undergoing Treatment Interventions

Resource links provided by NLM:


Further study details as provided by ViOptix Canada:

Estimated Enrollment: 100
Study Start Date: August 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >= 18 years old
  • PAD
  • Chronic Critical Limb Ischemia
  • requiring surgical intervention
  • able to give informed consent

Exclusion Criteria:

  • emergent/urgent requirement for surgical intervention
  • requiring surgical intervention due to acute traumatic injury
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224328

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
ViOptix Canada
Investigators
Principal Investigator: Thomas Lindsay, FRCSC, FACS Toronto General Hospital, University Health Network
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00224328     History of Changes
Other Study ID Numbers: VIO-UHN-001
Study First Received: September 13, 2005
Last Updated: September 11, 2007
Health Authority: United States: Food and Drug Administration
Canada: Therapeutic Products Directorate

Keywords provided by ViOptix Canada:
Tissue Oxygen Saturation
Peripheral Arterial Disease
Critical Limb Ischemia
Near-infrared Spectroscopy

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014